Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)

Surgery Clinical Trial

Official title:

Prophylactic Nasal Continuous Positive Airway Pressure (nCPAP) Following Bowel Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316575
• Other study ID #: ANES-3
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether prophylactic nasal continuous positive airway pressure (nCPAP) in the post-anaesthesia care unit (PACU) improves post-operative pulmonary function following elective bowel surgery. The investigators hypothesize that one hour of nCPAP in the PACU will result in a higher partial pressure of arterial oxygen (PaO2) when compared to the standard treatment of low flow oxygen applied by face mask.

Description:

Post-operative pulmonary complications, such as hypoxemia, pneumonia and respiratory failure, occur in 5-10% of patients following abdominal surgery. These post-operative pulmonary complications result in increased morbidity, mortality, ICU admission, length of hospital stay and resource use.

CPAP has shown to be an effective treatment for hypoxemia following abdominal surgery. It decreases atelectasis formation the risk of pneumonia. Application of nCPAP to treat hypoxemic respiratory failure following thoraco-abdominal surgery has shown to decrease endotracheal intubation.

Nasal CPAP has shown to be effective prophylaxis following elective cardiac and thoraco-abdominal aortic surgery. It reduces the incidence of hypoxemia, pneumonia, re-intubation and re-admission to the ICU. It has also shown to decrease the length of hospital stay.

The use of nCPAP immediately post-operatively in the PACU following abdominal surgery has not been evaluated. Nasal CPAP is better tolerated than full face mask CPAP. It allows for effective clearance of respiratory secretions, improved communication and decreases claustrophobic sensation. The PACU is a transition period from general anaesthesia into the post-operative recovery phase. During this time, residual anaesthetic causes decreased level of consciousness and sub-optimal respiratory effort. Reversal agent for neuromuscular blockade has often not reached its peak effect. Inadequate pain control may further decrease respiratory effort. This transition period may be when maximal atelectasis of alveolar lung units occurs. This time period may be optimal for the application of nCPAP for prophylaxis against hypoxemia. It may improve post-operative pulmonary function which could decrease post-operative morbidity, mortality, length of hospital stay and resource use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled to undergo elective laparotomy for bowel surgery

Exclusion Criteria:

• age < 18 years

• postoperative admission to the intensive care unit

• a history of allergy/intolerance to Ametop

Related Conditions & MeSH terms

• Postoperative Pulmonary Atelectasis
• Pulmonary Atelectasis
• Surgery

Intervention

Device:
• nCPAP
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
• Low Flow Oxygen
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Royal University Hospital Foundation

References & Publications (3)

Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829. Review. — View Citation

Kindgen-Milles D, Müller E, Buhl R, Böhner H, Ritter D, Sandmann W, Tarnow J. Nasal-continuous positive airway pressure reduces pulmonary morbidity and length of hospital stay following thoracoabdominal aortic surgery. Chest. 2005 Aug;128(2):821-8. — View Citation

Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar - Arterial Gradient	The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen	1 hour following admission to PACU
Secondary	Number of Participants Requiring Reintubation		Up to 2 weeks
Secondary	Number of Participants Requiring Admission to ICU		Up to 2 weeks
Secondary	Length of Stay in Hospital		Up to 2 weeks